Hybrid Document Control QA Engineer II

RXinsider LTD.; Cranberry Township (Butler County); Hybrid; USD 75,000 - 95,000; Full time

Job summary

Omnicell is seeking a Quality Engineer II, Document Control to strengthen our Document Control and Document Management System processes. You will report to the Director of Quality Assurance and partner with cross-functional teams across business units.

Responsibilities include leading Document Control activities, improving methods and tools, ensuring compliance with FDA CFR 820 and ISO standards, and training staff. You will interact with auditors and drive metrics for DMS effectiveness.

Qualifications

• Knowledge of Document Management Systems and QMS.
• Experience interfacing with senior management and external auditors.
• Bachelor's degree required; ISO 13485/9001 experience preferred.

Responsibilities

• Lead Document Control activities across multiple units per QMS.
• Establish and improve document control methods and tools.
• Ensure compliance with FDA CFR 820, ISO 9001, ISO 13485 as required.
• Demonstrate effectiveness to internal and external auditors/inspectors.
• Train and mentor staff on Document Control processes.
• Establish quality metrics for DMS and documentation processes.

Skills

Document Management Systems

Stakeholder communication

Relationship building

Change agent

Verbal & written communication

Time management

Decision making

Attention to detail

MS Office suite

Multi-project management

Self-starter

Analytical

Decisive

Education

Bachelor's degree

Tools

eQMS

Agile PM tools

Job description

Omnicell is seeking a Quality Engineer II, Document Control to strengthen our Document Control and Document Management System processes. You will report to the Director of Quality Assurance and partner with cross-functional teams across business units.

Responsibilities include leading Document Control activities, improving methods and tools, ensuring compliance with FDA CFR 820 and ISO standards, and training staff. You will interact with auditors and drive metrics for DMS effectiveness.